PostmenopausalPhase 3NCT00667667
Effects of Whole Body Vibration on Postmenopausal Risk-factors in Elderly Women
A Phase 3 study testing vertical vibration device (Vibrafit whole body vibration platform) and side alternating vibration device (Board 3000 whole body vibration platform) in people with Postmenopausal, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
There is general agreement that physical exercise can positively influence osteoporotic fracture risk along two pathways: first by reducing the risk of falls via an improvement of fall related neuromuscular abilities; second by increasing bone strength. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal
- What is being tested?
- vertical vibration device (Vibrafit whole body vibration platform) and side alternating vibration device (Board 3000 whole body vibration platform)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2008to Nov 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- females 60 - 75 years old
- caucasian race
Who cannot join
- CHD-diseases
- thrombosis, embolism
- fractures at lumbar spine or hip
- secondary osteoporosis
- hyperparathyroidism
- medication, diseases with impact on muscle or bone
- hip or knee implant
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Medical Physics, University of Erlangen-Nurnberg
Erlangen, 91052
About this study
Official title: Effect of Whole Body Vibration Training on Two Different Devices on Osteoporotic Risk Factors in Postmenopausal Women. A Randomized Controlled Trial.
There is general agreement that physical exercise can positively influence osteoporotic fracture risk along two pathways: first by reducing the risk of falls via an improvement of fall related neuromuscular abilities; second by increasing bone strength.
Whole body vibration (WBV) training has recently been proposed as a new approach for prevention and treatment of osteoporosis. Animal studies have shown evidence that WBV may be an effective method to improve bone mass, architecture and strength. However, the results of human WBV training studies are rather heterogeneous.
In the Erlangen Longitudinal Vibration Study II (ELVIS II), a randomized, controlled 12 month lasting study the investigators determine the effect of a thrice weekly WBV training on two different devices on the osteoporotic risk factors: bone mineral density, falls and neuromuscular performance. Particular the investigators compare a bipedal vertical oscillating Plate with a plate which rotates around a central axis leading to a side-alternating loaning.
- Conditions
- Postmenopausal
- Being tested
- vertical vibration device (Vibrafit whole body vibration platform), side alternating vibration device (Board 3000 whole body vibration platform), stretching and wellness (control group)
- Keywords
- whole body vibration, exercise, postmenopausal, BMD, bone, elderly females, Caucasian race
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vertical vibration device (Vibrafit whole body vibration platform)Device
3 sessions/week 15 min each, leg exercises performed on whole body vibration platforms with vertical device
side alternating vibration device (Board 3000 whole body vibration platform)Device
3 sessions/week 15 min each, leg exercises performed on whole body vibration platforms with side alternating device
stretching and wellness (control group)Behavioural
2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | vertical vibration device (using Vibrafit whole body vibration platforms) Receives: Device: vertical vibration device (Vibrafit whole body vibration platform) |
| 2 | Active comparator | side-alternating vibration device (using Board 3000 whole body vibration platforms) Receives: Device: side alternating vibration device (Board 3000 whole body vibration platform) |
| 3 | Sham comparator | wellness-control group Receives: Behavioral: stretching and wellness (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
Measured: Baseline, 12 months
Secondary outcomes (3)
muscle strength
Measured: baseline, 12 months
Quality of life
Measured: baseline, 12 month
falls
Measured: daily over 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PostmenopausalStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Elsbeth-Bonhoff-Stiftung, Berlin
- Responsible party
- Principal investigator, Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
- Investigators
- Simon O von Stengel, PhD, Principal investigator, University of Erlangen-Nürnberg Medical SchoolWolfgang K Kemmler, PhD, Study chair, Instiute of Medical PhysicsWilli A Kalender, Prof., PhD, Study director, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667667
- Sponsor's protocol ID
- OFZ-Elvis-II
- Status last verified
- May 2015
- First submitted
- 24 Apr 2008
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
von Stengel S, Kemmler W, Kalender WA, Engelke K, Lauber D. Differential effects of strength versus power training on bone mineral density in postmenopausal women: a 2-year longitudinal study. Br J Sports Med. 2007 Oct;41(10):649-55; discussion 655. doi: 10.1136/bjsm.2006.033480. Epub 2007 Jun 5.
PubMed 17550916Stengel SV, Kemmler W, Pintag R, Beeskow C, Weineck J, Lauber D, Kalender WA, Engelke K. Power training is more effective than strength training for maintaining bone mineral density in postmenopausal women. J Appl Physiol (1985). 2005 Jul;99(1):181-8. doi: 10.1152/japplphysiol.01260.2004. Epub 2005 Mar 3.
PubMed 15746294Kemmler W, Lauber D, Weineck J, Hensen J, Kalender W, Engelke K. Benefits of 2 years of intense exercise on bone density, physical fitness, and blood lipids in early postmenopausal osteopenic women: results of the Erlangen Fitness Osteoporosis Prevention Study (EFOPS). Arch Intern Med. 2004 May 24;164(10):1084-91. doi: 10.1001/archinte.164.10.1084.
PubMed 15159265
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole Body Vibration Training on Two Different Devices on Osteoporotic Risk Factors in Postmenopausal Women. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00667667
- Acronym / sponsor ID
- OFZ-Elvis-II
- Conditions
- Postmenopausal
- Keywords
- whole body vibration, exercise, postmenopausal, BMD, bone, elderly females, Caucasian race
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Elsbeth-Bonhoff-Stiftung, Berlin
- Study start
- Apr 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 28 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is general agreement that physical exercise can positively influence osteoporotic fracture risk along two pathways: first by reducing the risk of falls via an improvement of fall related neuromuscular abilities; second by increasing bone strength.
Whole body vibration (WBV) training has recently been proposed as a new approach for prevention and treatment of osteoporosis. Animal studies have shown evidence that WBV may be an effective method to improve bone mass, architecture and strength. However, the results of human WBV training studies are rather heterogeneous.
In the Erlangen Longitudinal Vibration Study II (ELVIS II), a randomized, controlled 12 month lasting study the investigators determine the effect of a thrice weekly WBV training on two different devices on the osteoporotic risk factors: bone mineral density, falls and neuromuscular performance. Particular the investigators compare a bipedal vertical oscillating Plate with a plate which rotates around a central axis leading to a side-alternating loaning.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: vertical vibration device (Vibrafit whole body vibration platform)vertical vibration device (using Vibrafit whole body vibration platforms) |
| 2 | Active comparator | Device: side alternating vibration device (Board 3000 whole body vibration platform)side-alternating vibration device (using Board 3000 whole body vibration platforms) |
| 3 | Sham comparator | Behavioral: stretching and wellness (control group)wellness-control group |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- females 60 - 75 years old
- caucasian race
Key exclusion criteria (7 listed)
- CHD-diseases
- thrombosis, embolism
- fractures at lumbar spine or hip
- secondary osteoporosis
- hyperparathyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vertical vibration device (Vibrafit whole body vibration platform)3 sessions/week 15 min each, leg exercises performed on whole body vibration platforms with vertical device | Device | 1 |
| side alternating vibration device (Board 3000 whole body vibration platform)3 sessions/week 15 min each, leg exercises performed on whole body vibration platforms with side alternating device | Device | 2 |
| stretching and wellness (control group)2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months | Behavioural | 3 |
Primary outcome
Bone Mineral Density
Time frame: Baseline, 12 months
3 secondary outcomes
muscle strength
Time frame: baseline, 12 months
Quality of life
Time frame: baseline, 12 month
falls
Time frame: daily over 12 month
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Background: PubMed 17550916von Stengel S, Kemmler W, Kalender WA, Engelke K, Lauber D. Differential effects of strength versus power training on bone mineral density in postmenopausal women: a 2-year longitudinal study. Br J Sports Med. 2007 Oct;41(10):649-55; discussion 655. doi: 10.1136/bjsm.2006.033480. Epub 2007 Jun 5.
- Background: PubMed 15746294Stengel SV, Kemmler W, Pintag R, Beeskow C, Weineck J, Lauber D, Kalender WA, Engelke K. Power training is more effective than strength training for maintaining bone mineral density in postmenopausal women. J Appl Physiol (1985). 2005 Jul;99(1):181-8. doi: 10.1152/japplphysiol.01260.2004. Epub 2005 Mar 3.
- Background: PubMed 15159265Kemmler W, Lauber D, Weineck J, Hensen J, Kalender W, Engelke K. Benefits of 2 years of intense exercise on bone density, physical fitness, and blood lipids in early postmenopausal osteopenic women: results of the Erlangen Fitness Osteoporosis Prevention Study (EFOPS). Arch Intern Med. 2004 May 24;164(10):1084-91. doi: 10.1001/archinte.164.10.1084.
- homepage of the Institute of Medical PhysicsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon O von Stengel, PhD principal investigator
University of Erlangen-Nürnberg Medical School
Wolfgang K Kemmler, PhD study chair
Instiute of Medical Physics
Willi A Kalender, Prof., PhD study director
University of Erlangen-Nürnberg Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing vertical vibration device (Vibrafit whole body vibration platform) and side alternating vibration device (Board 3000 whole body vibration platform) in people with Postmenopausal, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density (time frame: Baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00667667, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.